510(k) K801274
K801274 is an FDA 510(k) premarket notification submitted by Pennwalt Corp. for the device "S.S. WHITE-PENNWALT PRELUDE PIT SEALANT". The FDA issued a decision of Substantially Equivalent on June 9, 1980. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Pennwalt Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1980
- Date Received
- May 29, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Pit And Fissure, And Conditioner
- Device Class
- Class II
- Regulation Number
- 872.3765
- Review Panel
- DE
- Submission Type